An Investigation of Postoperative Pain, Why Still in Hospital and Days Alive and Out of Hospital Following Transoral Robotic Surgery for Squamous Cell Carcinoma of Unknown Primary and Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Patient-reported Pain intensity
Study Overview
Brief Summary
This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies.
- Randomized double-blinded clinical trial assigning half of the participants to a high-dose dexamethasone regimen while the other half will receive a low-dose dexamethasone dosage and placebo in the first postoperative period.
- A investigation of "Why in hospital?" following TORS. From the first postoperative day until discharge reasons for continued hospitalization will be registered in order to identify clinical and organizational factors contributing to hospitalization
- An assessment of "Days Alive and Out of Hospital" following TORS. From the day of surgery and the first 12 postoperative months all admissions to a hospital ward will be registered along with admission reasons. Any death during the first 12 months will be noted with a cause of death.
Detailed Description
The morbidity after TORS has not yet been fully investigated, but a recent studies suggest that pain is one of the primary causes for unplanned readmission This issue has been investigated by Clayburgh D et al who found that a prolonged dexamethasone regime lowered the pain scores on day three after surgery. The patients treated with the prolonged dexamethasone regime also showed a significant improvement in the food consistency they were capable to swallow and had a shortened length of stay (LOS). Recently, a pilot-study showed, that an intensified dexamethasone regime among TORS patients reduced the pain level to that of a standard tonsillectomy. Besides an analgesic effect glucocorticoids furthermore poses an anti-inflammatory quality which can be used to lower the physiological stress and inflammatory response following surgery and may prevent organ dysfunctions and complications The analgesic effect of dexamethasone has been the topic of many clinical studies, and are well described in various surgical fields. However, the optimal dose and regime for glucocorticoids prescription has so far not been established. The evidence favoring one dosage regime and an optimal prescribed dose is restricted by the variance in the regimes used in various clinical trials and the fact that there is a need for clinical trial investigating steroids with pain as the primary endpoint Consequently, it is important to thoroughly investigate and optimize the analgesic regime after TORS.
Hospitalization So far when evaluating the long-term consequences of TORS, the main focus has been on oncological outcomes and quality of life with attention to functional outcomes, i.e. feeding tube dependency and dysphagia while the LOS following TORS and why the patient is hospitalized after the procedure have been sparsely studied.
The reason why TORS patients are still hospitalized after the procedure and which clinical and organizational factors contribute to the hospitalization have not yet been examined and understood but is highly relevant in order to understand and improve the postoperative care.
A method to assess the efficiency of a therapy have emerged from the cardiology field and is called Days Alive and Out of Hospital (DAOH). This has been used in investigations of heart failure patients and myocardial infarction patients. This outcome combines mortality and morbidity, and accounts for the number but also duration of several hospitalizations after the primary discharge.
DAOH has only sparse been used in the surgical field, and only in few studies in the cardiac surgery area. The measurement is a patient-centered outcome that provide better information to the patient and surgeon when planning surgery, and can be used for quality improvement studies since it accounts for effective and efficient care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Ability to provide a written informed consent
- •ECOG/WHO performance status 0-2
- •Squamous cell carcinoma of unknown primary or obstructive sleep apnea
- •Booked for TORS based on radiologic and clinical assessment by an ENT surgeon oTORS for obstructive sleep apnea must be preceded by a Drug-induced sleep endoscopy (DISE) examination
- •Negative Urine HCG pregnancy test for women in the fertile age.
Exclusion Criteria
- •Serious medical comorbidities (ECOG/WHO performance status >2). Other contraindications to surgery
- •Distant metastasis
- •Active Herpes zoster
- •Previous head and neck cancer
- •Significant trismus, maximum inter-incisal opening 35mm
- •Insulin dependent diabetes
- •Allergy to glucocorticoids
- •Preoperative daily use of systemic glucocorticoids <90 days before the surgery Glucocorticoids administered to the patient's routine examination under general anesthesia with bilateral biopsies from base of the tongue, adenoidectomy and concurrent tonsillectomy are not a part of this exclusion criteria. Only systemic daily use <90 prior TORS is an exclusion criterion.
- •Preoperative use of biological anti-inflammatory medication <90 days before the surgery
- •Active gastric ulcer in the opinion of the investigator
- •Pregnancy/Breastfeeding
Arms & Interventions
Experimental
High dose Dexamethasone
Intervention: Dexamethasone (Drug)
Control
Standard dexamethasone dosage and placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Patient-reported Pain intensity
Time Frame: Postoperative day 1 until day 14 postoperatively
Visual analog scale (VAS) ranging from 0-10. 0 being no pain and 10 being maximum pain. The patient will twice daily self-assess pain-intensity during both rest and activity (swallowing). The pain-intensity will be noted in a pain-diary
Secondary Outcomes
No secondary outcomes reported
Investigators
Mikkel Hjordt Holm Larsen
Coordinating investigator, MD
Rigshospitalet, Denmark
